Cohorts of 3-6 patients receive escalating doses of Cp6 7909 until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. A total of 10 patients are treated at the MTD.

Blood is collected at baseline and at approximately day 40 for immunological studies, including immunoenzyme techniques, antibody response assays, and immunophenotyping.

After completion of study treatment, patients are followed every 3 months for 1 year.

Patients will be eligible to receive CpG 7909 and vaccines on or after day 60 post transplant. No patients are eligible for this protocol beyond day 74 post transplant. Therefore, all patients will start therapy on this protocol between days 60-74 post transplant to allow for patient scheduling flexibility.

Patients must have engraftment and be independent of transfusion support or growth factor support.

Patients must not have received platelet or red-cell transfusions in the previous week.

Patients must have been continuously off all growth factors for at least 1 week.

Unsupported counts must be:

platelets ≥ 50,000/ml

Hgb ≥ 9 gm/ul

Absolute neutrophil count ≥ 1000/µL

Absolute lymphocyte count ≥ 500/µL

Patients must have a current performance status of 0-1 (Eastern Cooperative Oncology Group) or 70-100% (Karnofsky.

Patients must be afebrile, off antibiotics therapeutic (not prophylactic), and free of evidence of active infection. Patients must be off intravenous (IV) hyperalimentation and IV fluids.

Patients receiving or scheduled to receive planned radiation therapy, growth factor therapy, or steroid therapy during the study period will be ineligible. Patients must have completed all planned post-transplant radiation therapy if applicable.

Patients must be able to give written informed consent and agree to comply with the study parameters

Expected to require additional cytotoxic therapy within 30 days of study

Receiving other post-transplant investigational agents

Patients with a history of autoimmune diseases will be ineligible for this protocol

It is unknown whether CpG 7909 may exacerbate autoimmune disorders by its immunomodulatory effects. Therefore, subjects with a history of autoimmune disease should not receive CpG 7909. Controlled thyroid disease is permissible.

Systemic corticosteroids or other immunosuppressants

Pregnant or lactating (It is unlikely and probably unwise that a women of childbearing potential become pregnant this early after transplant, however; if any suspicion, a pregnancy test should be done)

Not meeting one or more of the eligibility criteria, as listed above

Contacts and Locations

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study.
To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00369291